Modular apparatus for therapy of an animate body

ABSTRACT

Modular therapy apparatus for treatment of at least a portion of an animate body comprises a first modular member and a second modular member. The first modular member comprises a heat transfer device adapted to transfer heat between the device and the at least a portion of an animate body. The second modular member forms a pouch having a perimeter and is adapted to receive the first modular member. The second modular member comprises a front side and a back side. The front side has a hook portion, which forms the hook portion of a hook and loop fastener. The back side has a loop portion, which forms the loop portion of the hook and loop fastener. The second modular member can be wrapped around the at least a portion of an animate body and the hook and loop portions fastened to one another to secure the second modular member with the first modular member positioned therein to the at least a portion of the animate body.

FIELD OF THE INVENTION

The present invention relates to therapy of an animate body, and moreparticularly to modular heat transfer apparatus for treatment of atleast a portion of an animate body.

BACKGROUND OF THE INVENTION

It is now common to apply cold and compression to a traumatized area ofa human body to facilitate healing and prevent unwanted consequences ofthe trauma. In fact, the acronym RICE (Rest, Ice, Compression andElevation) is now used by many.

Cold packing with ice bags or the like traditionally has been used toprovide deep core cooling of a body part. Elastic wraps are oftenapplied to provide compression.

It will be appreciated that these traditional techniques are quiteuncontrollable. For example, the temperature of an ice pack will, ofcourse, change when the ice melts, and it has been shown that theapplication of elastic wraps and, consequently, the pressure provided bythe same, varies considerably even when the wrappers are experiencedindividuals.

Because of these and other difficulties, many in the field have turnedto more complicated animate body heat exchanger. Most effective animatebody heat exchangers typically include two major components, an externalcompliant therapy component covering a body part to be subjected to heatexchange, and a control component for producing a flowing heat exchangeliquid. Many control units also produce and supply an air or other gaspressure needed to apply pressure to a body part and to press the heatexchange liquid toward such body part. This air pressure is directed toanother compliant bladder of the therapy component, which air pressurebladder overlays the liquid bladder to press such liquid bladder againstthe body part to be subjected to heat exchange, as well as applycompression to the body part to reduce edema.

As can be seen, a commonly used external therapy component uses a pairof compliant bladders to contain fluids; that is, it preferably has botha compliant bladder for containing a circulating heat exchange liquidand a gas pressure bladder which overlays the liquid bladder forinhibiting edema and for pressing the liquid bladder against the bodypart to be subjected to heat exchange. One problem is that in manytherapy component configurations of this nature, the gas pressurebladder tends to “balloon” or, in other words, expand to a much greaterdegree than is desired. This unwanted expansion can be the cause ofseveral problems. For one, it can actually pull away from the body part,some or all of the conformal heat exchange bladder. For another, it canreduce its edema inhibition ability, as well as reduce the desiredeffect of pressing the heat exchange bladder into contact with the bodypart.

Commonly used external therapy components use hook and loop fasteningsystems in order to allow the therapy component to be applied to a widevariety of body sizes and to give skilled users maximum flexibility inapplication. The hook and loop fastener is commonly a permanent andintegral part of the therapy component, and can be attached by a varietyof means including but not limited to sewing, RF welding, gluing, andheat sealing. There are several problems with the permanent attachmentof a hook and loop fastening system to the therapy component. First,forces may resolve disadvantageously when the hook and loop fastener issecured, which can result in peeling the hook and loop fastener open anddecreasing effective compression. Second, a sewn assembly is relativelystiff, resulting in less even distribution of compression therapy, aswell as a higher probability of folds in the assembly that can causefluid flow to be cut off as compression increases. Third, the therapycomponent is typically in direct contact with the skin, but RF weldedsoft heat exchangers cannot be machine washed making it more difficultto provide sanitary treatment in clinical settings or in rentalsituations. Finally, hook and loop fasteners have a limited lifetime andwhen they wear out, the entire therapy component must be scrapped.

There remains a need to provide efficient heat transfer therapyapparatus and methods.

SUMMARY OF THE INVENTION

The present invention involves improvements in heat transfer therapyapparatus and avoids disadvantages in the prior art.

According to one embodiment of the invention, modular therapy apparatusfor treatment of at least a portion of an animate body comprises a firstmodular member comprising a heat transfer device adapted to transferheat between the device and the at least a portion of an animate body;and a second modular member forming a pouch having a perimeter andadapted to receive the first modular member, the second modular membercomprising a front side and a back side, the front side having a hookportion, which forms the hook portion of a hook and loop fastener, theback side having a loop portion, which forms the loop portion of thehook and loop fastener, whereby the second modular member can be wrappedaround the at least a portion of an animate body and the hook and loopportions fastened to one another to secure the second modular memberwith the first modular member positioned therein to the at least aportion of the animate body. Among the many advantages of the inventionis that it can improve effective delivery of therapy.

According to another embodiment of the invention, modular therapyapparatus for treatment of at least a portion of an animate bodycomprises a first modular member comprising a heat transfer deviceadapted to transfer heat between the device and at least a portion ofthe animate body; and a second modular member forming a pouch having aperimeter and adapted to receive the first modular member, the secondmodular member comprising a front side and a back side, the front sidehaving a hook portion, which forms the hook portion of a hook and loopfastener, the back side having a loop portion, which forms the loopportion of the hook and loop fastener, the loop portion beingnon-stretch material.

According to another embodiment of the invention, modular therapyapparatus for treatment of an animate body comprises a first modularmember comprising a heat transfer device adapted to transfer heatbetween the device and the animate body, the heat transfer devicecomprising a first bladder and a second bladder; the first bladderadapted to circulate a coolant and the second bladder being inflatable;and a second modular member forming a pouch having a perimeter andadapted to receive the first modular member, the first and secondmodular members being removable from one another after the first modularmember has been placed in the pouch.

According to another embodiment of the invention, a modular therapysystem for treatment of an animate body comprises a first modular membercomprising a heat transfer device adapted to transfer heat between thedevice and the animate body, the heat transfer device comprising a firstbladder for circulating coolant and a second bladder that is inflatable;a coolant source fluidly coupled to the first bladder; a gas sourcefluidly coupled to the second bladder; and a second modular memberforming a pouch having a perimeter and adapted to receive the firstmodular member, the first and second modular members being removablefrom one another after the first modular member has been placed in saidpouch.

According to another embodiment of the invention, a system for treatmentof differently sized animate body members comprises a first modularmember comprising a heat transfer device; a second modular memberforming a pouch having a perimeter and adapted to receive the firstmodular member, the second modular member comprising a front side and aback side, the front side having a hook portion, which forms the hookportion of a hook and loop fastener, the back side having a loopportion, which forms the loop portion of the hook and loop fastener; anda third modular member forming a pouch adapted to receive the firstmodular member; the second modular member comprising a front side and aback side, the front side having a hook portion, which forms the hookportion of a hook and loop fastener, the back side having a loopportion, which forms the loop portion of said hook and loop fastener,the third modular member pouch having the same configuration and size asthe second modular member pouch and the third modular member beinglarger than the second modular member.

According to another embodiment of the invention, a method of assemblingheat transfer apparatus for an animate body comprises providing aplurality of same sized bladders adapted for carrying heat transfermedium; providing a plurality of differently sized covers each with apouch, wherein the pouches are of the same size and are adapted toreceive a respective one of the bladders; selecting a cover; andinserting one of the bladders in the pouch of the selected cover.

The above is a brief description of some deficiencies in the prior artand advantages of the present invention. Other features, advantages, andembodiments of the invention will be apparent to those skilled in theart from the following description and accompanying drawings, wherein,for purposes of illustration only, specific forms of the invention areset forth in detail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the invention;

FIG. 2 illustrates top plan views of modular portions of the embodimentof FIG. 1;

FIG. 3 illustrates bottom plan views of the modular portions of FIG. 2;

FIG. 3A is an enlarged section of a portion of one of the modularportions of FIG. 3 illustrating a dot connection pattern;

FIG. 4 illustrates coupling the modular portions of FIG. 2;

FIG. 5A illustrates the modular portions of FIG. 4 with one modularportion enclosed in a pouch in the other or outer modular portion;

FIG. 5B illustrates a variation of FIG. 5A where the inner enclosedportion has the same dimension and the out modular portion, whichencloses the inner modular portion, is larger;

FIG. 6 is a sectional view taken along line 6-6 in FIG. 5A;

FIGS. 6A and 6B diagrammatically illustrate the true grain orientationof the heat transfer device layers illustrated in FIG. 6 in accordancewith one embodiment of the invention;

FIGS. 7A-C illustrate use of the embodiment of FIG. 1, where FIG. 7Aillustrates applying the apparatus to the arm of a human user; FIG. 7Billustrates the apparatus wrapped around the arm; and FIG. 7Cillustrates the apparatus wrapped around the lower portion or calf ofthe user;

FIG. 8 illustrates another embodiment of the invention;

FIGS. 9A-B illustrate use of the embodiment of FIG. 8, where FIG. 9Aillustrates the apparatus being wrapped around a human patient's upperleg and knee and FIG. 9B illustrates the apparatus fully wrapped aroundthat region and ready for use;

FIG. 10 illustrates bottom plan views of modular portions of anotherembodiment of the invention which, for example, is suitable for couplingto the patient's body core region;

FIG. 11 illustrates top plan views of the modular portions of FIG. 10;

FIG. 12 is a sectional view of the embodiment of FIG. 10 with themodular portions coupled;

FIG. 13A illustrates coupling of the modular portions so that onemodular portion is enclosed in a pouch in the other or outer modularportion;

FIGS. 13B and 13C show two positions of the embodiment of FIG. 10 afterinsertion of the one modular portion as shown in FIG. 13A, wherein FIG.13B shows the belt or strap portions arranged downward and FIG. 13C showthe belt or strap portions arranged upward;

FIGS. 14A-D diagrammatically depict use of the embodiment of FIG. 10where FIG. 14A show a first step in wrapping the apparatus around thewaist of a patient, FIG. 14B shows securing the apparatus in place, FIG.14C shows the apparatus being in its final position and ready for use,and FIG. 14D shows the apparatus with the straps repositioned and theapparatus being wrapped around the upper torso of the patient;

FIG. 15 illustrates another embodiment of the invention, which, forexample, can be used to treat the ankle and foot region of a patient;

FIG. 16 illustrates top plan views of modular portions of the embodimentof FIG. 15;

FIG. 17 illustrates bottom views of the modular portions of FIG. 16;

FIGS. 18A-C illustrate coupling the modular portions of the embodimentof FIG. 16. where FIG. 18A illustrates a first stage of inserting onemodular portion into the other modular portion, FIG. 18B illustratesanother stage of inserting the one modular portion into the other, andFIG. 18C illustrates the one modular portion fully inserted into theother modular portion;

FIGS. 19A-D illustrate use of the embodiment of FIG. 10, where FIG. 19Ashows a first stage in wrapping the device; FIG. 19B illustratessecuring mating hook and loop fastener portions around the foot; FIG.19C illustrates securing mating hook and loop fastener portions at theforward portion of the lower leg of the patient, and FIG. 19Dillustrates securing mating hook and loop fastener portions behind theankle and region adjacent thereto;

FIG. 20 illustrates another embodiment of the invention, which, forexample, can be used to treat the shoulder of a patient;

FIG. 21 illustrates top views of modular portions of the embodiment ofFIG. 20;

FIG. 22 illustrates bottom views of the modular portions of FIG. 21;

FIGS. 23A-D illustrate coupling the modular portions of FIG. 20, whereFIG. 23A illustrates a first stage where the modular portions aregenerally aligned, FIG. 23B illustrate inserting a portion of onemodular portion into the other modular portion, FIG. 23C illustratesanother stage where the one modular portion is fully positioned in theother, and FIG. 23D illustrates edges or flaps of the covering modularportion secured to enclose the other modular portion; and

FIGS. 24A-D diagrammatically illustrate use of the embodiment of FIG. 20where FIG. 24A shows a first stage in pulling the apparatus over the armand toward the shoulder of a patient, FIG. 24B illustrates wrapping theapparatus around the shoulder of the patient and securing mating hookand loop fastener portions around the arm; FIG. 24C illustrates securingmating hook and loop fastener portions to secure portions that wraparound the chest of the patient, and FIG. 24D illustrates the apparatusin position for use with an optional strap having one end attached tothe apparatus and mating hook and loop fastener portions secured to oneanother to form a loop for receiving the patient's arm.

FIG. 25 illustrates another embodiment of the invention, which can beused in equine applications;

FIG. 26 illustrates bottom views of modular portions of the embodimentof FIG. 25; and

FIG. 27 illustrates top views of the modular portions of FIG. 25.

DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described, it is to be understood thatthis invention is not intended to be limited to particular embodimentsor examples described, as such may, of course, vary. Further, whenreferring to the drawings, like numerals indicate like elements.

The invention comprises modular heat transfer therapy apparatus, whichincludes a first modular member or portion and a second modular memberor portion. The first modular member or portion comprises a heattransfer device and the second modular member portion forms a pouch inwhich the first modular member is placed. The first modular member canbe readily removed so that one can clean either or both the first andsecond modular members and/or replace either of the first and secondmodular members. For example, the second modular member can beconstructed of material so that it is washable and reusable so that thesecond modular member can be cleaned after being stained with blood orotherwise soiled. This can happen, for example, when there is blood inthe area of the portion of the animate body being treated.Alternatively, the second modular member can be made so that it is alow-cost single-user disposable product. The ability to remove the firstmodular member from the second modular member and clean or replace thelatter is especially advantageous when the apparatus is used ondifferent patients. Further, one can replace the first or second modularmember when portions thereof are beginning to fail after a long periodof use. With this construction, a faulty heat exchanger can be easilyreplaced. The ability to replace one modular member also can avoid theneed to dispose of the entire apparatus, thereby providing the abilityto reduce cost over time. The following description, which will readilymake apparent many other advantages of the invention, pertains toillustrative examples and is not provided to limit the invention.

Referring to FIG. 1, a perspective view of one embodiment of theinvention is shown and generally designated with reference numeral 100.Modular heat transfer therapy apparatus 100 generally comprises firstmodular member 102 and second modular member 104, which forms a coverfor the first modular member and in FIG. 1 is shown in the form of asleeve. In other words, apparatus 100 is adapted to be wrapped around atleast a portion of a patient's body and form a sleeve around thatportion.

In FIG. 1, first modular member 102 is inside the second modular member104 and hidden from view. In the illustrative embodiment, second modularmember 104 comprises two compliant bladders, outer bladder 106 (FIG. 2)and inner bladder 108 (FIG. 3), which form separate chambers such aschambers 106 a and 108 a for different fluids. Compliant bladders 106and 108 are generally parallel to one another (see FIG. 6) and are madeso as to preclude fluid communication therebetween or between chambers106 a and 108 a during use. Bladders 106 and 108 can be formed fromthree sheets of material with one forming a common inner wall forchambers 106 a and 108 a as will be described in more detail below.

More specifically, outer bladder 106 is adapted to receive a first fluidsuch as a gas (e.g., air), which can be regulated to provide the desiredamount of inflation of the bladder or pressure therein. This inflationor pressure affects the compressive force applied to the animate bodyduring use as will be further described below. Inner bladder 108 isadapted to receive a fluid, such as a coolant, which can be in the formof a cold liquid, to transfer heat away from the animate body part.Alternatively, the fluid supplied to inner bladder 108 can have atemperature higher than ambient so as to heat the animate body part. Inthe example illustrated in FIG. 1, a three port manifold 110 provides aport for a fluid such as air to be introduced and exhausted from bladder106 and fluid inlet and outlet ports for circulating fluid throughbladder 108. Each port is formed by a tubular member, which has one endadapted to receive a hose connector as is known in the art and anotherend adapted to be inserted into one of three tubes (not shown) extendingform the bladder (described below). Further, each of the manifold fluidinlet and fluid outlet tubular members or passageways can be providedwith a valve such as a spring loaded valve that is configured to allowthe passage of fluid therethrough when the fluid hose connectors arecoupled to the manifold and to prevent fluid flow therethrough when thefluid hose connectors are uncoupled from the manifold as is known in theart. In this manner, fluid such as a liquid coolant is blocked fromexiting fluid bladder 108 when the fluid hoses are uncoupled from themanifold. The gas port does not include a valve. As described above,there are three tubes extending from the bladders. One tube extends frombladder 106 and two tubes extend from bladder 108. The tubes extendingfrom bladder 108 can be placed adjacent to the tube extending frombladder 106 with the tube for bladder 106 above and between the tubesfor bladder 108. In manufacture, bladder 106 is formed with an openingand bladder 108 is formed with two openings to receive the tubes in theorientation described above. A tube, such as a polyurethane tube, ispositioned in each one of these openings and then welded to a respectivebladder to form a fluid tight seal therewith. The tubes extending fromthe bladders typically have an inner diameter of about 1/8 inch. Themanifold passageways typically have a diameter of about 1/4 inch.Manifold 110 can be inserted into the tubes to form a seal therewith.For example, each manifold tubular member end portion that mates with oris inserted into a respective tube extending from one or the otherbladder can be provided with tapered hose barbs to enhance the seal asis well known in the art. A suitable manifold construction is disclosedin U.S. Pat. Nos. 5,104,158 and 5,052,725, both to Meyer, et al. andboth entitled Two Piece Female Coupling. The disclosures of U.S. Pat.Nos. 5,104,158 and 5,052,725 are hereby incorporated herein byreference. The manifold, which carries or forms the tubular members, canbe configured to mate with the curves of the body when connected to themodular apparatus. It also can be provided with a ridge for fingerplacement to allow easier removal. A fluid circulation control unit asdiagrammatically represented in FIG. 7B and generally designated withreference numeral 180 is coupled to manifold 110 with tubing to fluidlycommunicate the therapy fluids to bladders 106 and 108 as will bedescribed in more detail below. It should be understood that othermanifold configurations and/or couplings to provide fluid flow betweenthe fluid source and the bladders can be used as would be apparent toone of skill in the art. For example, valves need not be provided in theliquid port couplings.

Referring to FIG. 6, further details of one embodiment of the heattransfer or heat exchange device will be described. The illustrativeheat transfer or heat exchange device includes compliant bladder 108,which circulates heat exchange fluid or liquid. This bladder is definedby a pair of generally parallel, flexible, or in other words, compliant,and fluid- or liquid-tight, walls or layers of material 152 and 154,which walls are sealed together by, for example, RF welding along theirperimeters. Compliant gas pressure bladder 106 which overlays heatexchange bladder 108 as illustrated to direct gas (most simply, air)pressure against the heat exchange bladder 106 to press it towards theportion of the body being treated. This compliant gas pressure bladder106 is also defined by a pair of generally parallel and flexible wallsor layers of material 150 and 152. In this embodiment, wall 152 is acommon wall, i.e., one side of the same aids in defining gas pressurebladder 106 whereas the other side aids in defining bladder 108. Thus,three compliant walls or sheets of material are all that is necessary todefine the two separate bladders. Wall or layer 150 is also secured towalls 152 and 154 via RF welding along its perimeter.

The connections in the interior of heat exchange liquid bladder 108include a relatively uniform distribution of dot connections as shown inFIG. 3A and designated with reference character “D.” This matrix ofconnections acts to disperse the liquid throughout the bladder. Thisdispersion is further aided by curvilinear fence connections providedfor the purpose of directing the flow of a liquid. These fenceconnections are indicated by the reference numeral F in FIG. 3A. In theillustrative embodiment, the dots are formed in a triangular grid.

During the manufacturing process, sheets of material defining the walls152 and 154 are RF welded together at the dot connections and at theinterior fences. At a later time, the wall 150 is RF welded to the otherwalls at the perimeter of the bladder. This RF welding will also form acommon border for walls 150, 152, and 154.

Referring to FIGS. 6A and 6B, the heat transfer or heat exchange deviceis welded with each of the three layers having a rotated true grain ofabout 10-30° with respect to one another. This grain rotation candramatically improve resistance to ripping of the heat exchanger. In theembodiment illustrated in FIG. 6B, sheets 150, 152 and 154 have graindirections indicated with arrows “A,” “B” and “C,” respectively. Graindirection B of sheet 152 is offset in a counterclockwise direction fromgrain direction A of sheet 150 by about 30°. And grain direction C ofsheet 154 is offset in a clockwise direction from grain direction A ofsheet 152 by about 30°.

Each of the walls 150, 152 and 154 can be made of a nylon materialsuitably coated with polyurethane to provide both the RF weldingqualities and the needed liquid or air impermeability. In one embodimentof the invention, the heat transfer or heat exchange device can comprisefabrics (e.g., nylon fabric) that are laminated with asymmetric amountsof polyurethane. That is, the inner surface of the outer wall of thecoolant chamber has an extra heavy coating, which corresponds to about a5 oz coating of polyurethane, while the inner surfaces of the otherwalls have standard coatings corresponding to about 3 oz coatings ofpolyurethane. Accordingly, the surfaces of the inner wall of the coolantand air chambers and the inner surface of the outer wall of the airchamber have standard 3 oz coatings. This construction only requires onenon-standard fabric (the fabric having the 5 oz coating), whileproviding the extra polyurethane necessary to produce an extremelyrobust weld capable of taking or withstanding over 25,000 cycles at 30psi. This construction can reduce manufacturing costs. It alsofacilitates using a lighter weight fabric, which can result in a moreflexible heat exchanger that can better fit to the body. In anotherembodiment of the invention, the inner wall of the coolant chamber has a5 oz coating of polyurethane in order to facilitate a yet stronger bondat the expense of increased manufacturing costs due to the use of asecond non-standard fabric. A finish on the nylon material can alsoprovide a permanent antimicrobial finish to prevent mold growth.

Referring to FIGS. 2 and 3, top plan and bottom views of second modularmember 104 are shown. Modular member 104 comprises an inner or frontside portion 112 and an outer or back side portion 114. Member 104 canbe made from various materials and can comprise inner and outer sheetsof material that are sewn or fused together. For example, the inner andouter sides can comprise two sheets of fabric, which are sewn togetherto form seam 116. An additional seam 118 is provided so that seams 116and 118 form flap or marginal portion 120 and the perimeter of pouch122, which is adapted to receive first modular member 102. Binding canbe provided around the perimeter of second modular member 104 as shownin FIG. 6.

Outer back side portion 114 of second modular member has an opening 124formed therein for receiving first modular member 102 as shown in FIG.4. A portion of back side 114, such as portion 126, can be pulled back(FIG. 2) to facilitate positioning the remaining portion of firstmodular member 102 into the pouch. Numeral 114 a indicates the innersurface of back side portion 114 and is shown in the inner surfaceportion 126. Any suitable fastening means can be used to close opening124. For example, zipper 127 can be provided along the sides of theopening.

Second modular member 104 also includes a fastener for holding theapparatus in the desired location on the animate body. Accordingly, whenthe apparatus is wrapped around a portion of or the entire region beingtreated, the fastener holds the apparatus in place during treatment. Inthe illustrative embodiment, a hook and loop fastener is used. It shouldbe understood that if the hook and loop fastener wears out, theremovable second modular member or sleeve can be readily replaced.

Referring to FIG. 2, the loop material portion 128 of the hook and loopfastener can be integrally formed with or placed over essentially all ofouter back side portion 114 of second modular member 104. Alternatively,a strip of loop material can be integrally formed with or placed over aportion or the entire length (measured from the upper to lower edge ofmember 104 while referring to FIG. 2) of outer back side portion 114along the side opposite flap 120. The hook material portion of the hookand loop fastener is shown in FIG. 3 and generally designated withreference numeral 130. Hook portion 130 can be in the form of a singlestrip that extends along the height of inner front side portion 112(measured from the upper to lower edge, of inner front side portion 112)or it can be integrally formed with front side portion 112 in the sameregion. It can extend about 50% to 100% of the length of portion 112.Alternatively, hook portion can comprise a plurality of strips, whichcan be spaced along the length of portion 112.

In the illustrative embodiment, the active areas of the hook and loopfastener are outside the seams forming pouch 122. When compressionincreases, the forces may tend to resolve as shear forces as compared toother forces that can peel the hook portion from the loop portion.

According to one embodiment, loop portion 128 is non-stretch material.What is meant by non-stretch material or non-stretchable material ismaterial that stretches less than or equal to 3% of its length when heldin tension under a load of no more than 10 pounds. The non-stretch loopportion can improve the efficacy of compression on the animate body whenthe apparatus is in place. Loop portion 128 can be made of non-stretchmaterial, which can be woven or non-woven fabric. Alternatively, loopportion 128 can be made by securing loop material or fabric tonon-stretch backing material, which can be woven or non-woven fabric.The non-stretch backing material, for example, can be made of nylon orTyvek® (strong yarn linear polyethylene). The non-stretch and loopmaterials can be sewn, fused, or laminated together. Accordingly, outerback side portion 114 can comprise first and second materials where thefirst material is non-stretch material (e.g., non-stretch woven ornon-woven fabric), the second material is loop material and thenon-stretch material forms backing for the loop material.

The second modular member 104 or sleeve also can have a permanentantimicrobial finish to prevent mold growth, such as finishes madeaccording to military specification MIL.STD.810D. The finish can beapplied by placing the fabric in a chemical dip as is known in the art.The second modular member or sleeve can act as a blood barrier toprevent contamination of the heat exchanger and reduce transmission ofbacteria from patient to patient. For example, the inner faces of thesecond modular member that form the pouch and contact first modularmember 102 can be nylon with a durable water repellency (DWR) coating,which is typically a ½ ounce polyurethane coating.

FIG. 5A illustrates the modular portions of FIG. 4 with the firstmodular member inside second modular member 104 and zipper 127 closingopening 124. In this state, the apparatus is ready to apply to theportion of the body to be treated. Further, the pouch that secondmodular member 104 forms allows first modular member 102 to floattherein. In other words, beyond being confined in pouch 122, there areno connections between first and second modular members 120 and 104.This can provide a more evenly distributed compression around the gasbladder, resulting in improved therapy of the body being treated.Further, since the heat exchange device can move within pouch 122, thereis less chance that a portion of the heat exchange device blocks coolantflow when the apparatus is improperly applied to the portion of the bodybeing treated. For example, if an improper fold occurs in the heatexchange device, the heat exchange device may self-correct its positionand relieve blockage of coolant flow.

An exemplary use of modular therapy apparatus 100 will be made withreference to FIGS. 7A-C. This example is provided for illustration andis not intended to limit the scope of the invention. Referring to FIG.7A, apparatus 100 is positioned adjacent to a portion of a humanpatient's arm to be treated with the apparatus in an open state.Apparatus 100, which is coupled to fluid circulation and pressurizingunit 180, is then wrapped around the patient's arm and the secondmodular member hook portion 130 along flap 120 fastened to a portion ofthe loop portion of member 104.

The control unit includes a mechanism for cooling and circulating aliquid coolant, which includes a reservoir for containing ice water. Ina practical realization of this embodiment, the liquid is normal tapwater. This liquid was cooled by placing ice into the ice box portion ofthe control unit, resulting in temperatures ranging typically between40° F. and 50° F. In this connection, the control unit accepts liquidthat has been returned from the heat exchange bladder 108. Beforereintroducing the heat exchange liquid into bladder 108, it can be mixedwith the liquid in the reservoir or it can be directed to bypass thereservoir. That is, the control unit is capable of supplying liquid atother controlled temperatures by means of mixing liquid chilled in theice box and liquid warmed in the bladder by means of contact with ananimate body and returning the mixed liquid to the bladder. The pressureof air furnished by the control unit is generally about 0.25 to 1.5psig.

It should be noted that the invention is applicable to many other typesof therapy components, and the particular liquid, its temperature andpressure will be dependent upon the design and purpose of such therapycomponents. This is also true of the air pressure and in some instancesit is cycled between two pressures (typically between 1.5 and 0.25psig). Similarly, the second modular member can have various shapes toaccommodate different areas of an animate body. Typically, the area ofone side of the second modular member will range from about 1 to 6square ft. In the case of the knee application, this area will be about6 square ft. In the case of an elbow, this area will be about 1 to 1.5square ft.

Although apparatus 100 has been described with a dual bladder heatexchange device, a single bladder heat exchange device can be used. Inthe single bladder embodiment, the bladder is adapted circulate liquidor coolant.

FIG. 5B illustrates one variation of FIG. 5A. The embodiment of FIG. 5B,is the same at that shown in FIG. 5A with the exception that secondmodular member is modified (as indicated with reference numeral 104′) sothat the portion of the second modular member outside and to the leftside of pouch 122 is larger. That portion is indicated with referencenumeral 121 and typically will have a width of at least 1 inch a morespecifically in the range of range of 1 to 12 inches. A further seam118′ also can be provided. The ability to enlarge the overall dimensionof the second modular member, while maintaining the configuration anddimension of pouch 122 unchanged facilitates using a single heatexchange device with many differently sized second modular members orsleeves to treat differently sized patients or different body portions.Accordingly, another embodiment of the invention comprises a system fortreatment of differently sized members. The system includes a pluralityof differently sized second modular members each having a pouch 122 ofthe same configuration and size and a plurality of first modular members102, each adapted to fit in any of the pouches or each being of the samesize and configuration. The second modular member can be selected basedon the animate body portion being treated and combined with any one ofthe heat exchange devices.

Referring to FIG. 8, another embodiment of the invention is shown andgenerally designated with reference numeral 200. Modular therapyapparatus 200 is the same as apparatus 100 with the exception that it islarger and its configuration is slightly modified so that it betteradapted to from a sleeve around ones upper leg and knee as shown inFIGS. 9A and 9B. Accordingly flap 220, which includes a hook portionthat is hidden from view, is the same as flap 120 with the exceptionthat it is larger and its configuration is slightly modified as shown inthe drawings.

Referring to FIGS. 10 and 11, another embodiment of the invention isshown and generally designated with reference numeral 300. As will bedescribed in more detail below, apparatus 300 can be used, for example,to treat the core or torso of a human body. FIG. 10 illustrates bottomplan views of the modular portions of apparatus 300 and FIG. 11illustrates top plan views of the modular portions of FIG. 10.

Apparatus 300 comprises first modular member 302 and second modularmember 304. First modular member 302 includes gas bladder 306 and fluidor coolant bladder 308. Bladders 306 and 308 form chambers 306 a and 308a, respectively. Except for the configuration of first modular member302, first modular member 302 is the same as first modular member 102and can be made in the same manner, with the exception that a pluralityof connections between the walls defining the modular member or airbladder 302 can be provided.

More specifically, and with reference to FIG. 12, which a sectional viewof apparatus 300, a plurality of connections between the walls definingmodular member or air bladder 302 can be provided as described in U.S.Pat. No. 6,695,872 to Elkins, the disclosure of which is herebyincorporated herein by reference. Such connections can minimize oreliminate undesirable ballooning when the bladder is pressurized. In theillustrative embodiment, in which the bladders are formed by RF welding(see e.g., FIG. 12), this is simply achieved by forming some of theconnections normally provided in liquid bladder 308, while sheet 350 isin place as will be described in more detail below. The result is thatthese connections are also formed in air bladder 306, that is, theseconnections are both within the liquid bladder and in the air bladder.It appears functionally as if the desired connections provided in theliquid bladder are “telegraphed” also to appear in the air bladder.These connections in the two bladders, of course, register with oneanother.

In the illustrative embodiment, the shape of gas pressure bladder 306conforms to the shape of the heat exchange bladder 308. Fences ordividers in the heat exchange bladder to direct fluid flow can be alsoprovided in the gas pressure bladder. These control fences are indicatedby the reference numeral C in FIG. 12. They can be provided in bladder306 not only for the purpose of directing the flow of a liquid or gas,but also to secure the walls defining the gas pressure bladder togetherat various locations within the interior of such bladder. Theseconnections provided by the fences C can prevent the gas bladder from“ballooning” out as described above and causing the temperature controlliquid bladder not to conform to the body part. These fences registerwith the comparable fences in the liquid bladder.

During the manufacturing process, sheets of material defining the walls352 and 354 are RF welded together at the dot connections and ifdesired, at the interior fences. At a later time the wall 350 is RFwelded to the other walls at the perimeter of the bladder with anyinterior fences being formed as needed. Such fences C will thereby beformed in both bladders providing the desired liquid flow directors inthe liquid bladder and the connections in the air bladder. This RFwelding will also form a common border for walls 350, 352, and 354.

The inner fences construction also can be provided in the gas bladder ofthe embodiment of FIGS. 20-24, which is described in detail below.

Second modular member 304 is the same as second modular member 104 withthe exception that second modular member is differently configured andincludes central portion 304 a, and straps or strap portions 304 b and304 c. Strap portions 304 b and 304 c are secured to central portion 304a as will be described in more detail below. Second modular membercentral portion 304 a comprises an inner or front side portion 312 andan outer or back side portion 314. Central portion 304 a can be madefrom various materials and can comprise inner and outer sheets ofmaterial that are sewn or fused together as previously described inconnection with member 104 and can include seam 316 which defines theperimeter of pouch 322. Pouch 322 is adapted to receive first modularmember 302. Strap portions 304 b and 304 c can comprise one or morelayers of material. When more than one layer is used, the layers can besewn or fused together as would be apparent to one skilled in the art.

Outer back side portion 314 of central portion 304 a has an opening 324formed therein for receiving first modular member 302 as shown in FIG.13A. Any suitable fastening means can be used to close opening 124. Forexample, zipper 327 can be provided along the sides of the opening(FIGS. 13B & C).

Second modular member 304 also includes a fastener for holding theapparatus in the desired location on the animate body. Accordingly, whenthe apparatus is wrapped around a portion of or the entire region beingtreated, the fastener holds the apparatus in place during treatment. Asin the embodiments described above, a hook and loop fastener is be usedin this illustrative embodiment.

Referring to FIG. 11, the loop material portion 328 of the hook and loopfastener can be integrally formed with or placed over essentially all ofouter back side portion 314 of second modular member 304. Therefore, theloop material portion can cover the outer back side surface of centerportion 304 a, and strap portions 304 b and 304 c (FIG. 11).Alternatively, a strip of loop material can be integrally formed with orplaced over a portion or the entire length (measured from the upper tolower edge of member 304) adjacent the outer end of portion 304 c andalong interface with center portion 304 a. According to one embodiment,loop portion 328 is non-stretch material and can be made in the samemanner as loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens theapparatus to the animate body is shown in FIG. 10 and generallydesignated with reference numeral 330. Hook portion 330 is positioned onthe front side portion 312 of strap 304 b and can be in the form of asingle strip that extends along the outer end portion of strap 304 b orit can be integrally formed with the front side portion of 304 b. It canextend about 50% to 100% of the length of strap 304 b. Alternatively,hook portion can comprise a plurality of strips, which can be spacedfrom one another. Hook material portions 330 also are provided along theinner end portions of straps 304 b and 304 c. These portions are shownin dashed line in FIG. 10.

In the illustrative embodiment, the active areas of the hook and loopfastener on the outer end portions straps 304 b and 304 c are outsidethe seam forming pouch 122. When compression increases, the forces maytend to resolve as shear forces as compared to other forces that canpeel the hook portion from the loop portion. The hook and loop fastenerthat operates between the inner end portions of strap portions 304 b and304 c and center portion 304 a facilitate removal of the strap portions.This, in turn, facilitates replacement of either or both straps orrepositioning of the straps. For example, the straps can be portioned asshown in FIG. 13B, which may be preferred when treating the upper torsoof a patient. Alternatively, the straps can be removed and repositionedas shown in FIG. 13C, which may be preferred when treating the lowerportion of the patient's torso.

FIGS. 14A-D diagrammatically depict use of the apparatus 300 where FIG.14A show a first step in wrapping the apparatus around the waist orlower portion of the torso of a patient, FIG. 14B shows securing theapparatus in place, and FIG. 14C shows the apparatus being in its finalposition and ready for use. FIG. 14D shows the apparatus with the strapsrepositioned and the apparatus being wrapped around the upper torso ofthe patient.

Referring to FIG. 15, another embodiment of the invention is shown andgenerally designated with reference numeral 400. Modular therapyapparatus 400 can be used, for example, to treat an ankle and/or foot ofa patient. FIG. 16 illustrates top plan views of modular portions ofapparatus 400 and FIG. 17 illustrates bottom views of the modularportions of apparatus 400.

Apparatus 400 comprises first modular member 402 and second modularmember 404. First modular member 402 includes gas bladder 406 and fluidor coolant bladder 408. Bladders 406 and 408 form chambers 406 a and 408a, respectively. Except for the configuration of first modular member402, first modular member 402 is the same as first modular member 102and can be made in the same manner.

Second modular member 404 is the same as second modular member 104 withthe exception that second modular member is differently configured, hasdifferently positioned hook portions and has heel alignment marker 405.Accordingly, member 404 can be made from various materials and cancomprise inner and outer sheets of material that are sewn or fusedtogether as previously described in connection with member 104 and caninclude seam 416, which in combination with seams 418, defines theperimeter of pouch 422. Pouch 422 is adapted to receive first modularmember 402.

Outer back side portion 414 has an opening 424 formed therein forreceiving first modular member 402 as shown in FIG. 16. Zipper 427 canbe provided along the sides of the opening (FIG. 18C).

Second modular member 404 also includes a fastener for holding theapparatus in the desired location on the animate body and can includethe hook and loop fastener system described in connection with apparatus100. Referring to FIG. 11, the loop material portion 428 of the hook andloop fastener can be integrally formed with or placed over essentiallyall of outer back side portion 414 of second modular member 404.Alternatively, a strip of loop material can be integrally formed with orplaced over a portion of back side portion 414 that would cooperate withthe hook portions in accordance with FIGS. 17 and 19A-C. According toone embodiment, loop portion 428 is non-stretch material and can be madein the same manner as loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens theapparatus to the animate body is shown in FIG. 17 and generallydesignated with reference numeral 430. Hook portions 430 can have awidth of about 4 inches. In the illustrative embodiment, the activeareas of the hook and loop fastener are outside the seams forming pouch422, which can provide similar advantages to those described aboveregarding force resolution when the apparatus is under compression.

FIGS. 18A-C illustrate inserting the modular member 402 into modularmember 404. where FIG. 18A illustrates a first stage of insertingmodular member 402 into modular member 404. FIG. 18B illustrates anotherstage portion into the other and FIG. 18C illustrates member 402 fullyinserted and zipper 327 closed.

FIGS. 19A-D illustrate use of the embodiment of FIG. 10. First oneplaces one's foot on inner side portion 412 with one's heel alignedalong U-shaped marker 405. Flap V is wrapped over the foot and flap Wsecured thereto with hook portion 430 FIGS. 19A & B). Flap X is wrappedaround the ankle and leg and then flap Y is wrapped thereover andsecured thereto with hook portion 430 (FIG. 19C). Flap Z is then wrappedaround the leg and over flap Y and secured thereto with hook portion 430(FIG. 19D).

Referring to FIG. 20, another embodiment of the invention is shown andgenerally designated with reference numeral 500. Apparatus 500 can beused to treat the shoulder of a patient. FIG. 21 illustrates top viewsof the modular members of the apparatus 500 and FIG. 22 illustratesbottom views of the modular members shown in FIG. 21.

Apparatus 500 comprises first modular member 502 and second modularmember 504. First modular member 502 includes gas bladder 506 and fluidor coolant bladder 508. Bladders 506 and 508 form chambers 506 a and 508a, respectively.

First modular member 502 is the same as first modular member 102 exceptfor the configuration of modular member 502, including flap portions562, and that it can include the inner fence construction describedabove in connection with the embodiment of FIGS. 10-14. Modular member502 also differs from modular member 102 in that it includes a couplingmechanism for coupling these flap portions. More specifically, flapportions 562 are coupled to one another through elastic cord 560, whichis laced through holes formed in first modular member 502. The elasticcord substantially maintains flaps 562 in the closed position shown inFIG. 21 when bladder 506 is inflated and fluid circulated throughbladder 508.

Second modular member 504 is the same as second modular member 104 withthe exception that second modular member is differently configured andincludes central portion 504 a, and straps or strap portions 504 b, 504c, and 504 d. Strap portions 504 b, c & d are secured to central portion504 a as will be described in more detail below. Second modular membercentral portion 504 a comprises an inner or front side portion 512 andan outer or back side portion 514. The arm sling 540 can be coupled tosecond modular member 504 through a plurality of snap connectors “S” orany other suitable connector including but not limited to hook and loopfasteners. Central portion 504 a can be made from various materials andcan comprise inner and outer sheets of material that are sewn or fusedtogether as previously described in connection with member 104 and caninclude seam 516, which in combination seam 518, define the perimeter ofpouch 522. Pouch 522 is adapted to receive first modular member 502.Strap portions 504 b, c, and d can comprise one or more layers ofmaterial. When more than one layer is used, the layers can be sewn orfused together as would be apparent to one skilled in the art.

Outer back side portion 514 has an opening 524 formed therein forreceiving first modular member 502 as shown in FIG. 16. Zipper 527 canbe provided along the sides of the opening (FIG. 18C).

Second modular member 504 also includes a fastener for holding theapparatus in the desired location on the animate body and can includethe hook and loop fastener system described in connection with apparatus100. Referring to FIG. 21, the loop material portion 528 of the hook andloop fastener can be integrally formed with or placed over essentiallyall of outer back side portion 514 of second modular member 504.Alternatively, a strip of loop material can be integrally formed with orplaced over a portion of back side portion 514 that would cooperate withthe hook portions described below. According to one embodiment, loopportion 528 is non-stretch material and can be made in the same manneras loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens theapparatus to the animate body and generally designated with referencenumeral 530. The hook portion of strap portion 504 b can comprise twosections, each having a length extending along the length of the strapof about 4 or 5 inches. These sections can be spaced apart by about 1inch to facilitate or improve flexibility of the end portion of thestrap. In this manner, the strap can be readily folded to provide lengthadjustment for differently sized users. In the illustrative embodiment,the active areas of the hook portion of the hook and loop fastener areoutside the seams forming pouch 522, which can provide similaradvantages to those described above regarding force resolution when theapparatus is under compression.

FIGS. 23A-D illustrate coupling the modular members 502 and 504 whereFIG. 23A illustrates aligning modular member 502 with opening 524 insecond modular member outer back side portion 514. FIGS. 23B and C showinsertion of modular member 502 into modular member 504 and FIG. 24Dshows back side portion 514 closed and zipped up.

FIGS. 24A-D diagrammatically illustrate use of apparatus 500 where FIG.24A shows a first stage in pulling the apparatus over the patient's armand toward the patient's shoulder. FIG. 24B illustrates positioning theapparatus over the shoulder of the patient and securing hook portions ofstraps 504 c and 504 d to portions of central portion 504 a which areconstructed with loop material to secure apparatus 500 to the patient'sarm. Strap 504 b is then pulled under the patient's other shoulder and aportion of its hook portion is ready to be fastened to the loop materialof central portion 504 a (FIG. 24C). In FIG. 24C, the end portion ofstrap 504 b is folded back along the space between hook portions 530 andsecured in that position by tucking into a pocket designed to accept it.This facilitates shortening the strap for smaller patients. The endportion of strap 504 b can be unfolded to extend the length of the strapfor larger patients as shown in FIG. 24D. FIG. 24D also shows optionalstrap 640, which can be used to hold up the lower arm of the patient.Strap 540 can have a hook portion on one end and snaps at the oppositeend so that the hook portion can be fastened to loop material the outerside portion 514 or second modular member 504 and the snaps can befastened to the snaps on modular portion 504.

Referring to FIG. 25, a further embodiment of the invention is shown andgenerally designated with reference numeral 600. Apparatus 600 isespecially suited for equine applications. In FIG. 25, apparatus 600 isshown wrapped around at horse's leg. The therapy fluids are deliveredthough the hose 601, which has one end coupled to apparatus 600 throughmanifold 110 and its other end coupled to a therapy fluid circulationcontrol unit such as control unit 160. Accordingly, conduit 601 can havethree channels for fluid flow (e.g., two for liquid or gas coolant andone for gas). When a single apparatus is used, conduit 601 is directlyfluidly coupled to a fluid circulation control unit. However, when it isdesired to treat two legs, a Y-connector can be provided as shown inFIG. 25. One such Y-connector is diagrammatically shown and indicatedwith reference numeral 603. In this case, another conduit such asconduit 605 fluidly couples the Y-connector 603 with the circulationcontrol unit (not shown). The Y-connector facilitates fluidly couplingeach conduit 601, which is fluidly coupled to a respective apparatus 600through a manifold 110, to the circulation control unit so that aplurality of legs (i.e., 2) can be treated at the same time.

FIG. 26 illustrates bottom plan views of modular portions of apparatus600 and FIG. 17 illustrates top views of the modular portions ofapparatus 600. Apparatus 600 comprises first modular member 602 andsecond modular member 604. First modular member 602 includes gas bladder606 and fluid or coolant bladder 608. Bladders 606 and 608 form chambers606 a and 608 a, respectively. Except for the configuration of firstmodular member 602, first modular member 602 is the same as firstmodular member 102 and can be made in the same manner.

Second modular member 604 is the same as second modular member 104 withthe exception that second modular member is differently configuredincluding differently configured hook portions 630. Accordingly, member604 can be made from various materials and can comprise inner and outersheets of material that are sewn or fused together as previouslydescribed in connection with member 104 and can include seam 616, whichdefines the perimeter of pouch 622. Pouch 622 is adapted to receivefirst modular member 602. Inner side portion 612 is placed against theportion of the body being treated and outer back side portion 614 has anopening formed therein for receiving first modular member 602. Theopening is shown closed with zipper 627 in FIG. 27.

Second modular member 604 also includes a fastener for holding theapparatus in the desired location on the animate body and can includethe hook and loop fastener system described in connection with apparatus100. Referring to FIG. 27, the loop material portion 628 of the hook andloop fastener can be integrally formed with or placed over essentiallyall of outer back side portion 614 of second modular member 604.Alternatively, it can be integrally formed with or placed over the rightportion of zipper 627 or the side of zipper 627 opposite flaps 620.According to one embodiment, loop portion 628 is non-stretch materialand can be made in the same manner as loop portion 128 as describedabove.

The hook material portion(s) of the hook and loop fastener that fastensthe apparatus to the animate body is shown in FIG. 26 and generallydesignated with reference numeral 630. Hook portions are integrallyformed with or secured to flaps 620, which extend outward form seam 618.Hook portions 630 are can have a width of about 3 inches and a length ofabout 12 to 30 inches.

Regarding manufacture, it can be specialized to make the first modularmember, second modular member and any desired configuration thereof.Further, a plurality of any of apparatus 200, 300, 400, 500, and 600 canbe provided with differently sized second modular members, but with samesized pouches and same sized first modular members to facilitatecomponent interchangeability in a manner similar to that described inconnection with FIG. 5B.

Variations and modifications of the devices and methods disclosed hereinwill be readily apparent to persons skilled in the art. As such, itshould be understood that the foregoing detailed description and theaccompanying illustrations, are made for purposes of clarity andunderstanding, and are not intended to limit the scope of the invention,which is defined by the claims appended hereto. Any feature described inany one embodiment described herein can be combined with any otherfeature of any of the other embodiment whether preferred or not.

1. Modular therapy apparatus for treatment of at least a portion of ananimate body comprising: a first modular member comprising a heattransfer device adapted to transfer heat between said device and said atleast a portion of an animate body; and a second modular member forminga pouch having a perimeter and adapted to receive said first modularmember, said second modular member comprising a front side and a backside, said front side having a hook portion, which forms the hookportion of a hook and loop fastener, said back side having a loopportion, which forms the loop portion of said hook and loop fastener,whereby said second modular member can be wrapped around said at least aportion of an animate body and said hook and loop portions fastened toone another to secure the second modular member with said first modularmember positioned therein to the at least a portion of the animate body.2. The apparatus of claim 1 wherein said backside portion comprisesfirst and second materials, said first material being non-stretchmaterial and said second material being loop material, said non-stretchmaterial forming backing for said loop material.
 3. The apparatus ofclaim 2 wherein said first and second materials are sewn together. 4.The apparatus of claim 2 wherein said first and second materials arelaminated.
 5. The apparatus of claim 2 wherein said first materialcomprises fabric.
 6. The apparatus of claim 5 wherein said fabric isnon-woven fabric.
 7. The apparatus of claim 5 wherein said fabric iswoven fabric.
 8. The apparatus of claim 1 wherein said loop portion isnon-stretch material.
 9. The apparatus of claim 8 wherein said loopportion is non-stretch fabric.
 10. The apparatus of claim 9 wherein saidfabric is woven fabric.
 11. The apparatus of claim 9 wherein said fabricis non-woven fabric.
 12. The apparatus of claim 1 wherein said back sideincludes an outer marginal portion outside said perimeter, said outermarginal portion comprising said loop portion.
 13. The apparatus ofclaim 12 wherein said back side outer marginal portion comprisesnon-stretch fabric.
 14. The apparatus of claim 12 wherein said frontside includes an outer marginal portion outside said perimeter, saidfront side marginal portion comprising said hook portion.
 15. Theapparatus of claim 1 wherein said first modular member is movable withinsaid pouch when said pouch is closed.
 16. The apparatus of claim 1wherein said back side comprises first and second straps, each having aninner face and an outer face, said hook portion being arranged alongsaid first strap inner face and said loop portion being arranged alongsaid second strap outer face.
 17. The apparatus of claim 16 furtherincluding releasable fasteners, said straps being releasably coupled tosaid second modular member through said releasable fasteners.
 18. Theapparatus of claim 17 wherein said straps are repositionable on saidsecond modular member through said releasable fasteners.
 19. Theapparatus of claim 1 wherein said second modular member pouch includesat least two regions and an opening between said at least two regions,said second modular further including a fastener for fastening saidopening closed.
 20. The apparatus of claim 19 wherein said opening isformed in said back side.
 21. The apparatus of claim 1 wherein saidsecond modular member pouch has at least two regions, an opening betweensaid at least two regions, and a zipper fastener arranged in thevicinity of said opening for selectively opening and closing saidopening.
 22. The apparatus of claim 21 wherein said opening is formed insaid back side.
 23. The apparatus of claim 1 wherein the said secondmodular member covers a maximum area in the range of about 1 to 6 squarefeet.
 24. The apparatus of claim 1 wherein the said second modularmember covers a maximum area of about 6 square feet.
 25. The apparatusof claim 1 wherein said second modular member covers a maximum area inthe range of about 1 to 1.5 square feet.
 26. The apparatus of claim 1wherein said first modular member comprises a bladder.
 27. The apparatusof claim 1 wherein said first modular member comprises a plurality ofbladders.
 28. The apparatus of claim 1 wherein said first modular membercomprises first and second bladders.
 29. The apparatus of claim 28wherein said first and second bladders form separate chambers.
 30. Theapparatus of claim 28 wherein said first bladder includes an inlet portand an outlet port and said second bladder includes a port.
 31. Modulartherapy apparatus for treatment of at least a portion of an animate bodycomprising: a first modular member comprising a heat transfer deviceadapted to transfer heat between said device and said at least a portionof the animate body; and a second modular member forming a pouch havinga perimeter and adapted to receive said first modular member, saidsecond modular member comprising a front side and a back side, saidfront side having a hook portion, which forms the hook portion of a hookand loop fastener, said back side having a loop portion, which forms theloop portion of said hook and loop fastener, said loop portion beingnon-stretch material.
 32. The apparatus of claim 31 wherein said loopportion comprises first and second materials, said first material beingnon-stretch material and said second material being loop material, saidnon-stretch material forming backing for said loop material.
 33. Theapparatus of claim 31 wherein said heat transfer device comprises atleast one bladder.
 34. The apparatus of claim 33 where said heattransfer device comprises two bladders, one of said bladders adapted tocirculate coolant and the other one of said bladders adapted to beinflated.
 35. Modular therapy apparatus for treatment of an animate bodycomprising: a first modular member comprising a heat transfer deviceadapted to transfer heat between said device and said animate body, saidheat transfer device comprising a first bladder and a second bladder;said first bladder adapted to circulate a coolant and said secondbladder being inflatable; and a second modular member forming a pouchhaving a perimeter and adapted to receive said first modular member,said first and second modular members being removable from one anotherafter said first modular member has been placed in said pouch.
 36. Theapparatus of claim 35 wherein said first and second bladders formseparate chambers.
 37. The apparatus of claim 35 wherein said firstbladder includes an inlet port and an outlet port and said secondbladder includes a port.
 38. The apparatus of claim 35 wherein saidsecond modular member comprises a front side and a back side, said frontside having a hook portion, which forms the hook portion of a hook andloop fastener, said back side having a loop portion, which forms theloop portion of said hook and loop fastener, said loop portion beingnon-stretch material.
 39. A modular therapy system for treatment of ananimate body comprising: a first modular member comprising a heattransfer device adapted to transfer heat between said device and saidanimate body, said heat transfer device comprising a first bladder forcirculating coolant and a second bladder that is inflatable; a coolantsource fluidly coupled to said first bladder; a gas source fluidlycoupled to said second bladder; and a second modular member forming apouch having a perimeter and adapted to receive said first modularmember, said first and second modular members being removable from oneanother after said first modular member has been placed in said pouch.40. The system of claim 39 wherein said second modular member comprisesa front side and a back side, said front side having a hook portion,which forms the hook portion of a hook and loop fastener, said back sidehaving a loop portion, which forms the loop portion of said hook andloop fastener, said loop portion being non-stretch material.
 41. Asystem for treatment of differently sized animate body memberscomprising: a first modular member comprising a heat transfer device; asecond modular member forming a pouch having a perimeter and adapted toreceive said first modular member, said second modular member comprisinga front side and a back side, said front side having a hook portion,which forms the hook portion of a hook and loop fastener, said back sidehaving a loop portion, which forms the loop portion of said hook andloop fastener; and a third modular member forming a pouch adapted toreceive said first modular member; said second modular member comprisinga front side and a back side, said front side having a hook portion,which forms the hook portion of a hook and loop fastener, said back sidehaving a loop portion, which forms the loop portion of said hook andloop fastener, said third modular member pouch having the sameconfiguration and size as said second modular member pouch and saidthird modular member being larger than said second modular member. 42.The system of claim 41 wherein said loop portions are non-stretchmaterial.
 43. The system of claim 41 wherein said first modular membercomprises a bladder.
 44. The system of claim 41 wherein said firstmodular member comprises a plurality of bladders.
 45. The system ofclaim 44 wherein said bladders form separate chambers.
 46. A method ofassembling heat transfer apparatus for an animate body comprising:providing a plurality of same sized bladders adapted for carrying heattransfer medium; providing a plurality of differently sized covers eachwith a pouch wherein the pouches are of the same size and are adapted toreceive a respective one of said bladders; selecting a cover; andinserting one of said bladders in the pouch of said selected cover.